This funding opportunity announcement (FOA) encourages
grant applications for national Biomedical Technology Research Resources
(BTRR). These Resources conduct research and development of new or improved
technologies driven by the needs of basic, translational, and clinical
researchers. The Resources are charged to make their technologies available
to the research community in a sustainable manner, to provide user training,
and to disseminate the Resource’s technologies and experimental results.
Resources should be at the leading edge of their field with respect to both
technology development and engagement of the relevant research community. New
applicants are strongly encouraged to submit a pre-application in response to PAR-17-315 The pre-application process provides feedback on whether the proposed
technology development is appropriate for the NIGMS BTRR program, and the
potential competitiveness of a full application.

Key Dates

Posted Date

June 14, 2017

Open Date (Earliest Submission Date)

August 25, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

September 25, 2017; January 25, 2018; May 25, 2018;
January 25, 2019; May 25, 2019; and January 25, 2020, by 5:00 PM local time
of applicant organization. All types of non-AIDS
applications allowed for this funding opportunity announcement are due on
these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

January 7, 2018; May 7, 2018; September 7, 2018; May 7,
2019; September 7, 2019; and May 7, 2020, by 5:00 PM local time of applicant
organization. All types of AIDS and
AIDS-related applications allowed for this funding opportunity
announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Scientific Merit Review

February 2018; July 2018; November 2018; July 2019;
November 2019; July 2020

Advisory Council Review

May 2018; October 2018; January 2019; October 2019; January
2020; October 2020

Earliest Start Date

June 2018; December 2018; April 2019; December 2019; April
2020; December 2020

Expiration Date

May 8, 2020

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically using ASSIST or an
institutional system-to-system solution; paper applications will not be
accepted. ASSIST replaces the Grants.gov downloadable forms currently used with
most NIH opportunities and provides many features to enable electronic
multi-project application submission and improve data quality, including:
pre-population of organization and PD/PI data, pre-submission validation of
many agency business rules and the generation of data summaries in the
application image used for review.

Required
Application Instructions

It is critical that applicants follow the Multi-Project (M)
Instructions in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the Grants.gov
downloadable forms currently used with most NIH opportunities. Conformance
to all requirements (both in the Application Guide and the FOA) is
required and strictly enforced. Applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

Technology Research and Development (TR&D) is the
central activity of a BTRR. Research teams create critical, often unique,
technologies at the forefront of their respective fields. In support of that
mission, the Resources are structured to foster two kinds of collaborations: dynamic,
short-term Technology Development Partnerships (Partnerships) with other
technology developers, where appropriate, will enable the Resource to adopt and
incorporate emerging capabilities in rapidly evolving fields. BTRR
investigators must be able to recognize significant parallel contributions by
other technology developers, determine whether collaboration is appropriate,
and if so, establish mutually beneficial partnerships. While a BTRR is expected
to operate at the leading edge of a technology area, it is important to
recognize and exploit advances emerging from other academic research groups.

Similarly, Driving Biomedical Projects (DBPs) are biomedical
research test-beds that allow BTRR investigators to test nascent technologies
in the context of challenging problems in basic, translational, and clinical
research, while providing biomedical researchers with the earliest possible
access to these emerging tools. A deep understanding of needs and opportunities
in the relevant areas of biomedical research is an essential prerequisite for
all technology development. In a BTRR, this understanding is most clearly
expressed through successful engagement of those researchers best positioned to
benefit from early access to emerging tools.

BTRR investigators are expected to actively engage both
researchers who are developing technologies relevant to the Resource’s mission,
and the scientists in the community whose research may benefit from these
emerging technologies. However, the BTRR should not merely integrate and offer
access to technologies developed elsewhere. A BTRR is expected to develop
leading technologies that will significantly impact a broad community of
biomedical researchers, and through leadership within the relevant communities,
support the integration of those technologies into the larger context of the
relevant field. A successful BTRR will establish and maintain a leading role in
the development and early application of important enabling technologies. NIGMS
expects that most Research Resources will not be renewed beyond three cycles.

The relatively stable and substantial support of a BTRR
allows researchers to address the full range of technology development,
including early stage, high risk projects, iterative improvement in the context
of challenging real-world problems, and the refinement and optimization of
technologies to improve performance and promote the broadest possible
dissemination and adoption. The success of BTRR-supported technology
development is ultimately measured by adoption in the broader biomedical
research community. It is essential that technology development be carried
through to completion, including the optimization and dissemination of tools
with strong potential for continued impact.

The technology development mission of a BTRR should be
characterized by a focus on genuine completion of the development cycle for
each promising technology, in a timely manner, and a drive toward obsolescence
of the BTRR through ubiquity of the developed technology within the community.

Achieving sustainable community access to the technologies
developed by a Resource is critical to the success of the BTRR program. The
funding lifetime of a BTRR will in most cases not continue beyond fifteen
years. Over that time, there should be multiple overlapping cycles of
innovation, maturation, and dissemination of technologies that enable
biomedical research in a continuing, sustained manner. In discussing the
sustainability of Resource technologies, it is important to recognize that the
goal of the program is to make the technology itself available on a sustainable
basis, rather than making the Resource per se self-sustaining. The ultimate
goal of a Resource should be to change the way researchers use and think of a
technology that it is integrated into the relevant fields and spreads well beyond
its origin. A successful resource can eventually make itself superfluous.

Resources promote the adoption and use of technologies
through a robust program of Community Engagement (CE). Ultimately, the approach
to community engagement is largely left to the discretion of the Resource Program
Director/Principal Investigator (PD/PI). It is understood that some
technologies are more readily shared, replicated, or commercialized than
others, and unique constraints may dictate unique approaches. Further, BTRR
investigators are encouraged to use novel, creative approaches to engage
different segments of the biomedical research community. The phrase 'community
engagement' describes a process, rather than the goals of that process. The
process is emphasized because active engagement with the research community is
central to achieving those goals, which are to provide the broadest possible
access to emerging technologies, both within and beyond the Resource, moving
those technologies out into the community as quickly and effectively as
possible.

Active engagement of the relevant biomedical research
community is essential for development of an informed, competent user base who
can subsequently adopt the technology as it moves out of the Resource. This
includes access to the technology as it matures within the BTRR, direct
hands-on training in data acquisition and interpretation, and to the extent
possible, availability of the technology outside the Resource. Technologies are
moved out of the Resource quickly to promote the broadest and most sustainable
availability possible.

Details concerning current BTRRs can be found at https://publications.nigms.nih.gov/btrrs/.
The BTRR program is investigator-initiated. Applications in a wide range of
biomedical technologies are welcome. New applicants are strongly encouraged to
submit a pre-application (see PAR-17-315).
The pre-application process provides feedback regarding appropriateness for
this program and competitiveness of a potential application.

The National Institute of Biomedical Imaging and
Bioengineering (http://www.nibib.nih.gov,
NIBIB) has a similar program that supports Biomedical Technology Resource
Resources. Details about that program can be found at https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers.
Applicants who are interested in submitting an application to the NIBIB program
need to follow the NIBIB application procedures rather than those in this
announcement. Applicants are encouraged to investigate both the NIGMS and NIBIB
programs, and contact Institute staff, who can determine which program is a
better fit for their proposed center.

Technology
Research and Development: A BTRR may focus on advancement of a
single technology area or the development of an integrated approach to a
general class of problems. (See the NIGMS BTRR program
web page for numerous examples of each type of Resource.) BTRRs may be
developed in a specific technological area. For example, a Resource might focus
on instrumentation and methods development for a specific instrument type. In
contrast, a Resource may integrate multiple technologies to create
transformative approaches to a class of research problems.

Regardless of the scope of the TR&D activities
undertaken, a BTRR is an inherently multidisciplinary enterprise, requiring a
range of specialized expertise to address complex technical and biomedical
challenges. For example, these projects may involve development or significant
modification of instruments and associated control and data analysis systems,
development of new computer algorithms and related software, new physical or
chemical methods to prepare samples for analysis, new reagents, or development
of innovative applications through the integration of existing technologies.

While the historical focus of the program has been the
invention, development, and adaptation of technologies rooted in the physical
and mathematical sciences, such as major instrument platforms or data
visualization and analysis software, technology rooted in biological and
molecular sciences are also appropriate. Regardless of the specific
technologies involved, the essential common feature of a BTRR is the assembly
of a critical mass of both technological and intellectual resources with the
intent of developing and exploiting advances in technology and methods for
biomedical research.

These Resources create tools that can substantially improve
present approaches to a wide variety of problems in the biomedical sciences. A
successful BTRR will drive a virtuous cycle in which technological advances
facilitate biomedical inquiry, leading to new questions which in turn motivate
further technical innovation. This is accomplished through a synergistic
interaction of technical and biomedical expertise, both within the Resources
and through intensive collaborations with other leading laboratories. Ideally,
these Resources identify opportunities for transformative technological
advances that open new lines of biomedical inquiry. They also should be
uniquely positioned to recognize biomedical research problems that are solvable
by the creation of new tools. This intense synergy between technology
development and community-driven biomedical problem-solving defines the
Resources as fundamentally different in character from laboratories engaged in
research projects that may have more narrowly defined, inwardly-focused goals.

Driving
Biomedical Projects: Development of new biomedical research
tools is most effective when pursued in the context of challenging problems. A
BTRR, by virtue of its latitude to pursue the full spectrum of technology
development, can fully exploit the benefits of test-bed biomedical projects as
nascent technologies evolve. The Driving Biomedical Projects (DBPs) of a BTRR
are a set of biomedical research projects that will be pursued by the Resource
in collaboration with outside investigators to provide a context for the
demonstration, integration, and refinement of Resource technologies. This
collection of projects is an essential aspect of a BTRR's mission, and a
significant investment of time and effort by the Resource.

DBPs are collaborative projects. Resource personnel are
expected to work jointly with investigators outside the Resource who have
expertise in a particular biomedical discipline, and have reached a point in
their research where the availability of new technologies offers significant
benefits. The BTRR should support the work done in the Resource. However, the
collaborating investigators may not receive financial support from the Resource
for the work that they do in their laboratory.

DBPs should be selected on the basis of both their potential
for significant biomedical impact and their appropriateness as test beds for
new technology. A DBP should either: (a) present an opportunity to clearly
demonstrate the significant impact of technologies under development in the
Resource, or (b) represent a research problem hindered by a significant
technical challenge that motivates the Resource’s technology development,
driving it forward. Realistically, in most cases, DBPs will function in both of
these roles: if not simultaneously, then at different stages in the virtuous
cycle between technology development and biomedical inquiry. The selected
biomedical research projects should present substantial technical challenges
providing the opportunity for an iterative push-pull relationship to develop
between TR&D and the DBPs, advancing both. Such efforts are expected to
lead to joint publications. For new Resources in particular, it is sometimes
difficult to envision short-term impact of technology development on DBPs
because the new tools are still being developed. DBPs are test-bed projects,
and will often require substantial iterative feedback between the Resource and
collaborators, even to establish sample requirements and experimental
parameters. Impact of technologies will generally evolve gradually as these
parameters are clarified and the complexity of experiments increases. DBP
collaborators are characterized by a willingness to persevere through early
failures in order to benefit as early as possible from the successful
application of emerging technologies.

Community
Engagement: A BTRR is expected to serve as a resource for the
biomedical research community and must have a national impact. Leadership of a
Resource must include a clear vision for the relevance and potential impact of
the technologies under development, and a strong desire to realize that vision
through active engagement of the biomedical research community. This intense
focus on Community Engagement (CE) activities sets the BTRR program apart from
other NIH research centers. For a BTRR to be successful, Resource staff must
actively work with researchers who need access to technology and expertise,
including hands-on training for outside investigators. The Resource must also
invest effort in achieving genuine dissemination of the technology and methods
it has developed. These efforts require the commitment of significant financial
and personnel resources to activities outside of their primary research focus.
Providing other investigators with ready access to Resource tools and expertise
has a substantial impact on the administration and daily operation of the
laboratory.

Substantive, ongoing efforts to disseminate technologies and
train non-specialists in their use require a fundamentally outward-looking
philosophy, as well as enthusiasm for engaging the research community. The goal
of these efforts is, so far as is possible, to export the technology and
expertise of the Resource into the community, achieving a broader impact on
biomedical research than would be possible through the projects in which the
Resource can participate directly. Industrial partnerships are not required,
but they are welcome when appropriate. Ultimately, the CE elements of the
Resource should aim for the widespread and routine application of the
technologies being actively disseminated. An extended technology development
cycle might require a Renewal application for full feasibility, maturation and
community adoption. However, it is expected that most Research Resources will
not be renewed beyond three cycles and all Renewal applications will require a
sustainability plan.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

The maximum budget that may be requested is $800,000 in recurring
direct costs, excluding equipment. Applications requesting more than this
amount in recurring costs will not be reviewed. Because of the
technology-intensive nature of these Resources, there may be a need to
acquire specialized equipment. Equipment requests are expected to vary with
the nature of the technology development projects proposed. Funds for such
specialized equipment may be requested in excess of the $800,000 operating
limit if well justified.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum project period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which
requires renewal at least annually. The renewal process may require as much
time as the initial registration. SAM registration includes the assignment of a
Commercial and Government Entity (CAGE) Code for domestic organizations which
have not already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your
administrative office for instructions if you plan to use an institutional
system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic multi-project
applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Tech R and D (use for each Technology Research and
Development Project)

6

Driving Bio Proj (use for Driving Biomedical Projects
Portfolio)

6

Comm Engag (use for Community Engagement)

12

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

Revision applications must include an Overall component and
the components that are affected by the revision. Therefore, the component
requirements listed below may not apply to the revision application.

The application should consist of the following components:

Overall: required

Administration and Management: required

Technology Research and Development Projects: required, maximum 5

Driving Biomedical Projects Portfolio: required, maximum 1

Community Engagement: required, maximum 1

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell
lines from other components should be repeated in cell line table in Overall
component.

Research & Related Other
Project Information (Overall)

Follow standard instructions.

Project/Performance Site
Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance
Sites in the Overall section of the assembled application image in eRA Commons
compiled from data collected in the other components will be generated upon
submission.

Research & Related
Senior/Key Person Profile (Overall)

Include only the Project
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
this FOA) for the entire application.

A summary of Senior/Key Persons
followed by their Biographical Sketches in the Overall section of the assembled
application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included
in the Overall component is the Estimated Project Funding section of the SF424
(R&R) Cover.

A budget summary in the Overall
section of the assembled application image in eRA Commons compiled from
detailed budget data collected in the other components will be generated upon
submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is
required in the Overall component.

Specific Aims: Describe the
overall aims of the proposed Resource.

Research Strategy: Provide an overview of the
proposed BTRR. Describe the rationale for the Resource and its anticipated
impact on biomedical research. Discuss the technological theme(s) at the heart
of the Resource that are intended to address those opportunities. Describe the
complementary roles of the various Technology Research and Development
(TR&D) projects in advancing technical capabilities. Discuss the Driving
Biomedical Projects (DBPs), as well as broader strategies for Community
Engagement (CE), explaining why the projects and plans presented in detail in
the corresponding components of the application will position the BTRR to bring
the subject technologies into broad use. This section should include an
explicit discussion of the integration of all of the BTRR components to form a
coherent whole which will effectively develop and share enabling technologies.

The Overall Research Strategy should present the
rationale for the proposed BTRR. This includes the needs and opportunities in
the research community that will be addressed by the Resource, the overall
technical approach for meeting those needs, and why the proposed work is timely
and potentially effective. The value of the proposed Resource should be
discussed in the context of currently available technologies as well as other
ongoing technology development efforts.

The projected arc of the Resource’s technology
development program should be presented, placing the Research Strategy in that
context and referencing plans for sustainability of the technologies, including
how the proposed technology development plan will result in technologies that
can be adopted beyond the Resource. This section should describe the
complementary nature of the TR&D projects, including the rationale for
inclusion of Technology Development Partnerships, if any.

This section should also describe the overall themes
of the DBPs, the motivation for selection of the projects included in the
application, and the expected interaction of the DBPs with the TR&D
projects.

Provide an overview of the general approach to CE,
and how the complementary elements of Collaboration & Service, Training,
and Dissemination will be integrated to maximize the impact of the Resource.
Describe in broad terms the special constraints or opportunities for CE that
are presented by the nature of the technology being developed. This section
should describe, in light of those factors, the overall philosophy and broad
plans to accomplish the elements of CE.

The Overall Research Strategy should include an
annotated timeline that describes how the various projects relate to one
another and the target dates for availability of technologies. This is intended
only to describe the research plan and should not be interpreted by applicants
or reviewers as a series of milestones. Challenging technology development
projects are not always predictable.

This section should include preliminary data that is
broadly supportive of the technological approach, if appropriate. In Renewal
applications, this component should also include a progress report describing
the major advances and national impact achieved in the previous performance
period. However, specific progress in each of the component areas (TR&D,
DBPs, CE) should be included in those components when appropriate.

Progress
Report Publication List: For renewal applications, the title
and complete references to all publications, manuscripts accepted for
publication, patents, and other referenceable materials that have resulted from
the BTRR since it was last reviewed competitively must be included in the
publication list. All publications directly resulting from BTRR funded effort
must explicitly acknowledge support from the BTRR award, and be included in the
publication list. These publications should be distinguished from those that do
not benefit directly from BTRR funding. See Appendix instructions below.

Letters of Support: All
letters of support should be included in the most relevant component, and
should not be duplicated. Letters applicable to the entire application, such as
those expressing institutional support, should be included in the Overall
component. Letters of support from investigators specifically collaborating
with Resource investigators on any TR&D, DBP, or other projects described specifically
in the application should be included in the respective component. The purpose
of letters of support is to describe the nature of the collaborative
relationship, including its scope, and any special circumstances (e.g.
materials or technology transfer, or intellectual property agreements). Do not
include letters of support from resource users whose interactions are limited
to activities described in the CE component.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan. Detailed
plans for active recruitment of collaborators and sharing of intellectual and
technological resources is a fundamental aspect of any BTRR. Plans should be
briefly described here, referring the reader to the salient Components of the
application.

Appendix:

Do not use the Appendix to
circumvent page limits. Follow all instructions for the Appendix as described
in the SF424 (R&R) Application Guide with the following modification.

The application may include a list
of publications indirectly resulting from effort in the Resource. This is not
required. Indirectly-supported publications include work that benefited from
the existence of resources developed by the BTRR, but involved no active
engagement or effort by the Resource. An indirectly-supported publication
might, for example, cite the use of Resource-developed software downloaded and
used independently by a non-Resource investigator. These publications may be
listed as evidence of the secondary impact of the BTRR, beyond the investigators
actively working with the Resource. This is a measure of the effectiveness of
the center’s Community Engagement efforts and the value of Resource
technologies in the broader community.

PHS Human Subjects and Clinical Trials Information (Overall)

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the SF424
(R&R) Application Guide must be followed.

Project Narrative: Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.

Project /Performance Site
Location(s) (Administration and Management)

List all performance sites that
apply to the specific component.

Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field. The PD/PI must serve as the
Project Lead of the Administration and Management component'

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Administration and
Management)

Budget forms appropriate for the
specific component will be included in the application package.

The PD/PI is required to dedicate a minimum of 3
person months effort to this program.

Funds should be requested in the Consultant Costs
category of the budget for support of External Advisory Committee (EAC) member
travel expenses for the annual EAC meeting. The funds will be restricted for
this purpose, and may not be re-budgeted without prior approval by program
staff.

Equipment that will be applicable
beyond a single project should be requested in the Administration and
Management component. A justification should be supplied for the equipment
requested for the Resource. Price quotes should be included for major items of
equipment costing more than $25,000. The budget justification section should
include an evaluation of alternative instruments or manufacturers along with a
discussion of the proposed procurement plan.

Note: The R&R Budget form included
in many of the component types allows for up to 100 Senior/Key Persons in
section A and 100 Equipment Items in section C prior to using attachments for
additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administration
and Management)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of
the Administration and Management functions of the proposed center.

Research Strategy: This section should be
broken down into: Organizational Structure and Staff Responsibilities, Resource
Operating Procedures, the External Advisory Committee (EAC) and Sustainability
Plan.

Organizational
Structure and Staff Responsibilities: Describe the organizational
structure of the BTRR. Indicate the relationship of the Resource to the
administrative structure of the applicant institution. Describe how the PD/PI
and the proposed Resource staff will be organized with respect to the Resource
components: each of the TR&D projects, DBPs, CE, and Administration and
Management functions.

Describe specific plans to ensure that the BTRR
functions as a well-integrated multidisciplinary team, rather than a collection
of separate laboratories or projects linked by a common thematic interest. It
is expected that the PD(s)/PI(s) will provide leadership and direction to the
key components of the Resource. This includes directing and coordinating the
TR&D project leaders, overseeing the progress and turnover of DBP projects,
and ensuring proper access to Resource resources through Collaboration and
Service, Training and Dissemination activities. PD(s)/PI(s) are expected to be
fully engaged in all of these activities.

If multiple PDs/PIs are proposed, the application
must describe in detail the structural and procedural elements that will ensure
this integration and prevent fragmentation of the center. Funds and personnel
effort should not simply be divided among PDs/PIs who pursue their respective
aims independently. It should not be presumed that the best way to organize
Resource projects is along organizational boundaries, or the boundaries between
the research activities of the individual PDs/PIs. The organizational structure
of the Resource, particularly the TR&D projects, should be carefully
justified. This is distinct from the mPD/PI Leadership Plan because the focus
here is on the rationale for the organization of the research projects
independent of the individual leaders involved. That is, this section should
address the scientific rationale for the organization of the projects
themselves and why it is justified on a basis other than the boundaries between
research groups.

Resource
Operating Procedure: Describe operating procedures and policies
planned for the Resource. Include criteria and mechanisms to review requests
for the use of the equipment and facilities in the Resource and to schedule
that use once it has been approved. Describe criteria and process for
prioritizing and selecting any collaborative projects, such as Technology
Partnerships, DBPs, or if applicable, Collaboration and Service projects.
Include instructions on how users are to acknowledge support provided by the
Resource in any resulting publications.

External
Advisory Committee: Each BTRR must have an External Advisory
Committee (EAC). The EAC is appointed by the PD(s)/PI(s) and advises the
PD(s)/PI(s) on future directions for the Resource, particularly in planning
additional grant applications and in setting priorities for allocation of
Resource facilities. The committee chair should be knowledgeable about the
Resource's technology and the science it serves, but should not be a member of
the Resource staff or a major user of the Resource. Other committee membership
should be balanced among scientists knowledgeable about the Resource’s
technology, experts in its application to biomedical research problems and
users of the technology.

EAC members and the chair should be from outside the
host institution. NIGMS encourages the inclusion of scientists who are not
affiliated with the Resource; however, inclusion of collaborators on the EAC is
not prohibited. Membership should be rotated periodically. The EAC should meet
at least annually and prepare a written report of its recommendations,
addressed to the PDs/PIs.

In this section of the application, the role of the
EAC should be described. The committee's role in advising on instrument
purchases, Technology Partnerships, reviewing DBP and other collaborative and service
projects for merit and appropriateness, allocating instrument time, and on the
research plans for the BTRR should be presented. In Renewal applications, names
of current committee members and a brief description of their qualifications
should be included. For applications for new centers, potential EAC members
must not be contacted or appointed prior to completion of the submission,
review, and funding process, and should not be named in the application;
however, the scientific disciplines of anticipated committee members that would
be represented on the EAC should be described. If an EAC was already
constituted before the applicant began preparation of the application, the
membership of that committee must be disclosed in the application.

A local executive committee or other local committee
appointed to deal with specialized topics may be proposed as an adjunct to the
EAC. The function and meeting schedule for these committees should be described
in this section.

Sustainability
Plan: Bearing in mind that NIGMS expects that most Research
Resources will not be renewed beyond three cycles, for both New and Renewal
applications, this section of the application should address the long-term
plans for achieving sustainable community access to Resource-developed
technologies and metrics for determining success of these plans. Sustainability
in the context of this program refers to continuing, long-term access to and
adoption of technologies and related resources beyond the life of the BTRR.
Many specific details of sustainability are addressed elsewhere. This
Sustainability Plan should deal directly with the anticipated lifetime of the
BTRR and the sustainability of the technology beyond that point. If there are
insurmountable obstacles to sustainability beyond the BTRR, a rationale for
continuation of the Resource may be presented here.

Letters of Support: All letters of
support should be included in the most relevant component, and should not be
duplicated. Letters applicable to the entire application, such as those
expressing institutional support, should be included in the Overall component.
Letters of support from investigators specifically collaborating with Resource
investigators on any TR&D, DBP, or other projects described specifically in
the application should be included in the respective component. The purpose of
letters of support is to describe the nature of the collaborative relationship,
including its scope, and any special circumstances (e.g. materials or
technology transfer, or intellectual property agreements). Do not include
letters of support from resource users whose interactions are limited to
activities described in the CE component.

Resource Sharing Plan: Individuals are
required to comply with the instructions for the Resource Sharing Plans as
provided in the SF424 (R&R) Application Guide.

Appendix:

Do not use the Appendix to
circumvent page limits. Follow all instructions for the Appendix as described
in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment
Report (Administration and Management)

Not Applicable.

Technology Research and Development Project

When preparing your application in ASSIST, use Component
Type ‘Tech R and D.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Technology
Research and Development Project)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Technology
Research and Development Project)

Enter Human Embryonic Stem Cells in each relevant
component.

Research & Related Other Project
Information (Technology Research and Development Project)

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Project /Performance Site Location(s)
(Technology Research and Development Project)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Technology Research and Development Project)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they participate.
When a Senior/Key person is listed in multiple components, the Biographical
Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Technology Research and
Development Project)

Budget forms appropriate for the specific component
will be included in the application package.

Note: The R&R Budget form included in many of the
component types allows for up to 100 Senior/Key Persons in section A and 100
Equipment Items in section C prior to using attachments for additional entries.
All other SF424 (R&R) instructions apply.

Support should be requested for all research and
project management activities related to the project. If one or more Technology
Development Partnerships is anticipated, and activities conducted outside of
the BTRR in the collaborating laboratories or personnel associated with the
collaborating laboratories will be supported by the BTRR grant, funds should be
requested through a consortium subcontract.

PHS 398 Research Plan (Technology
Research and Development Project)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims:Describe
the specific aims of this Technology Research and Development Project.

Research
Strategy: Describe the goals of the Technology Research and
Development (TR&D) project. Together, the TR&D projects are the central
focus of the BTRR application and serve as the foundation for all other
Resource activities. Present the Research Strategy in sufficient detail for
critical evaluation of the both the quality of the research and the role of the
project in the overall Resource. Describe why the TR&D project is at the
cutting edge of the technological field, with a goal of increasing the
technology’s impact on biomedical research.

The Research Strategy should address the background
and rationale for the project, its significance, and methods. All related
DBP(s) should be listed for each TR&D project. It is expected that the
TR&D projects will be related to each other and that the description of
these projects will show synergy among them. This synergy may be related to
multiple applications of a common underlying technology, or complementary
approaches supporting a common goal. The application should describe the
relationship and complementarity among these projects, and their support of the
overall goals of the BTRR. The inclusion of any TR&D should be clearly
supported by the overall rationale for the center.

Justify the approach proposed in light of potential
impact, and present alternative approaches to solving technological problems in
the event that the main conceptual thrust should prove unfeasible. Provide a
rationale for the risk balance proposed. The nature and scope of a BTRR support
the full spectrum of technology development, including early stage high-risk
projects, iterative improvements to evolving technologies in the context of
DBPs, and the refinement and optimization of technologies to foster their
dissemination. As a group, the TR&D projects proposed for a BTRR should
address all of these aspects. Elements of high risk (and potentially high
payoff) are appropriate in the TR&D projects, but so are more
straightforward optimization efforts.

For Renewal applications, new activities should be
specifically identified. The development of new, innovative technologies and
strong rationale for significant impact of technological R&D are important
considerations in reviewing renewal applications. Long-term support of a
Resource depends strongly on demonstrated commitment to the introduction and
application of new technologies and to serving biomedical investigators on a
national basis. However, it is expected that most Research Resources will not
be renewed beyond three cycles.

A TR&D project may include, if warranted, plans
for one or more Technology Development Partnership subprojects. A Partnership
is appropriate if adopting an innovative technology being developed in another
research group will significantly advance the TR&D program of the Resource.
Explain plans for the Partnership and provide the supporting rationale. Partnership
subprojects should be brief, generally one to two years, conducted as
funding-neutral collaborations analogous to DBPs. Alternatively, Partnerships
may be supported through redeployment of Resource funds as consortium
subcontracts.

Partnerships anticipated at the time an application
is submitted should be described. However, Partnerships may be initiated at any
time during the grant period at the discretion of the PD/PI(s), consistent with
NIH grant policy. It should not be expected that Partnerships will be supported
through supplements to either laboratory, except under extraordinary
circumstances. BTRRs have a long record of collaboration with industrial
partners. In general, industrial partnerships are funding neutral,
characterized by in-kind contributions of effort and equipment. The introduction
of Partnerships as an optional element of the TR&D program of a BTRR should
not be interpreted to suggest a change in the nature or implementation of
industrial partnerships.

BTRR components must be integrated to form a coherent
program. The two sections below must be included as specific subheadings in the
Research Strategy section of each TR&D project.

Technology
Development Integration: Describe the relationship of this TR&D
project to the overall technology development program of the BTRR. Discuss the
complementarity between this TR&D project and the other proposed TR&Ds.

Interaction
with DBPs: Describe how the TR&D project is responsive to the
emerging needs of the biomedical research community. To encourage synergistic
interaction, DBPs serving as test beds for TR&D projects must be included
in the application (see below). The relationship between TR&D projects and
DBPs must be described explicitly for each TR&D project. Provide a brief
discussion of which DBPs are enabled by the TR&D project. Note that a more
detailed discussion of the entire TR&D program's impact on the DBPs as a
whole is required in the DBP component of the application.

Describe plans for the optimization of technologies
to a point where dissemination is realistic. Such plans should be incorporated
in every TR&D project, across the entire TR&D program of the Resource.
As appropriate, relate TR&D optimization plans to dissemination plans for
the technologies.

A TR&D project should not focus on data
collection. However, in some cases, modest sub-projects designed to generate
data for use in technology development or testing may be included as a part of
a TR&D project. Such projects should be included only when data to test
tools, devices, or software are not available elsewhere, and they do not
substitute for DBPs.

Letters
of Support: All letters of support should be included in the
most relevant component, and should not be duplicated. Letters applicable to
the entire application, such as those expressing institutional support, should
be included in the Overall component. Letters of support from investigators
specifically collaborating with Resource investigators on any TR&D, DBP, or
other projects described specifically in the application should be included in
the respective component. The purpose of letters of support is to describe the
nature of the collaborative relationship, including its scope, and any special
circumstances (e.g. materials or technology transfer, or intellectual property
agreements). Do not include letters of support from resource users whose
interactions are limited to activities described in the CE component.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Human Subjects and Clinical Trials Information (Technology
Research and Development Project)

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Technology
Research and Development Project)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report
as described in the
SF424 (R&R) Application Guide.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Other
Attachments: The application must include a table of every DBP
being pursued. For Renewal applications, DBPs from the previous funding period
that are not continued in the Renewal application must also be included. Each
entry in the table must include:

The name of the primary collaborating investigator for the DBP

The institution of the PD/PI

The title of the project

The name(s) of BTRR personnel involved with the project

The TR&D project(s) with which the DBP interacts

A concise statement of how the DBP acts as a driver or test bed
for the BTRR’s TR&D program: provide rationale for the proposed approach to
the problem and impact of the expertise of the BTRR investigators and
technology on the project.

Innovation: A concise statement of the technological innovations
that will result from the DBP interaction with Resource TR&D and their
implications beyond this project.

Start and end (if applicable) dates for the DBP

The external funding source and status of the project, including
NIH grant number where applicable.

For renewal applications only: publications that have
resulted from the DBP

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Driving Biomedical Projects
Portfolio)

Budget forms appropriate for the specific component
will be included in the application package.

Note: The R&R Budget form included in many of the
component types allows for up to 100 Senior/Key Persons in section A and 100
Equipment Items in section C prior to using attachments for additional entries.
All other SF424 (R&R) instructions apply.

The BTRR budget should support the work done in the
Resource by BTRR personnel. However, the collaborating DBP investigators may
not receive financial support from the Resource for the work that they do in
their own laboratory.

PHS 398 Research Plan (Driving
Biomedical Projects Portfolio)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims:Describe
the aims addressed by inclusion of the Driving Biomedical Projects and their
rationale.

Research
Strategy: This component of a BTRR should describe a set of
biomedical research projects that will be pursued by the Resource in collaboration
with outside investigators, including the overall themes of the biomedical
research projects that constitute the basis for the DBPs, their driving
relationship to the Resource technology development program, and the
anticipated benefits of the collaborative interactions. The overarching purpose
of a collection of DBPs is to provide a context for the demonstration,
integration, and refinement of Resource technologies. This section of the
application should describe how the DBPs together address that broad goal. The
potential impact of the proposed technology development on these individual
scientific problems should also be clear. The Research Strategy should focus on
a broad discussion of the DBPs, their relationship to the TR&D projects,
their selection, monitoring, and turnover, and the impact of the BTRR on these
projects. Individual DBP projects must be listed in a table included in the Other
Attachments section (see above).

It is expected that turnover in DBPs will occur
during the project period. The rationale for selection of the DBPs included in
the application, and a process for recruiting, selecting, and terminating DBPs
should be presented in this section of the application. DBPs should be selected
on the basis of both their potential for significant biomedical impact and
their appropriateness as test beds for new technology. A DBP should either:
(a) present an opportunity to clearly demonstrate the significant impact of
technologies under development in the Resource, or (b) represent a research
problem hindered by a significant technical challenge that motivates the
Resource’s technology development, driving it forward. Realistically, in most
cases, DBPs will function in both of these roles: if not simultaneously, then
at different stages in the virtuous cycle between technology development and
biomedical inquiry. The selected biomedical research projects should present
substantial technical challenges providing the opportunity for an iterative
push-pull relationship to develop between TR&D and the DBPs, advancing
both. The Research Strategy should treat the DBPs as a whole, discussing the
major biomedical research themes represented by the projects, the rationale for
anticipated Resource impact in those areas, and in the case of renewal applications,
demonstrated impact.

DBPs are collaborative projects. Describe plans for
Resource personnel to work jointly with DBP investigators outside the Resource.
For new Resources in particular, it is sometimes difficult to envision
short-term impact of technology development on DBPs because the new tools are
still being developed. DBPs are test-bed projects, and will often require
substantial iterative feedback between the Resource and collaborators, even to
establish sample requirements and experimental parameters. Impact of
technologies will generally evolve gradually as these parameters are clarified
and the complexity of experiments increases. DBP collaborators are
characterized by a willingness to persevere through early failures in order to
benefit as early as possible from the successful application of emerging
technologies. Describe the planned approach to establishing and strengthening
collaborative relationships with DBP investigators. For renewal applications,
explain what has made these relationships successful.

Tripartite
Driving Biomedical Projects: In some cases, a DBP may involve, in
addition to the biomedical collaborators, additional technology partners. For
example, a BTRR might develop software for data interpretation, in
collaboration with both a laboratory gathering data and a biomedical
investigator whose research problem forms the basis for the experiments. This
is acceptable. In these cases, the role of each participant and the nature of
the collaborations among them should be described in the context of the
biomedical research problem that is serving as the DBP, and should be noted in
the table listing the projects. However, details of collaborative technology
development should be described in the relevant TR&D project components(s).

Purely technical collaborations focused on advancing
some aspect of TR&D are not considered DBPs and should be included within
the relevant TR&D project, either as a fundamental, ongoing element of that
project, or, if transient, as a Technology Development Partnership.
Collaborations with biomedical researchers that make use of the technology and
expertise of the BTRR but are not intended to serve as either a primary driver
or test bed for technology development should be included in the CE section (see
below).

Describe the breadth and scope of the portfolio of
DBPs engaged by the Resource. The DBPs should be broad in scope and involve a
variety of biomedical research areas. The Resource is expected to be highly
responsive to a national user community whose members are primarily grantees
and contractors of other NIH programs. It is the Resource’s responsibility to
identify user communities that both need and will use the research capabilities
to be provided by the Resource. The scope of a BTRR’s portfolio of DBPs should
be reflective of the breadth of the technology’s potential impact.

There is no specific number of DBPs expected in this
component, but at least one must be included. Every TR&D project must have
a driving relationship with at least one DBP. It is preferred that a DBP drive more
than one TR&D project. In Renewals, the number and breadth (both scientific
and geographic) of DBPs are expected to be richer than in new applications.
Because BTRRs must demonstrate a national scope and impact, applicants are
encouraged to seek out a significant number of DBPs outside their home
institutions. However, it is understood that in many instances there are
significant technical and logistical obstacles associated with distant
collaborations (e.g., access to patient populations, or the need for repeated
ready access to biological materials). In exceptional cases where a majority of
DBPs are local, the applicant should provide justification and rationalize this
with respect to the overall mission to achieve a national impact.

DBPs are expected in most cases to stem from ongoing
biomedical research projects that have already been peer reviewed. DBPs are
expected to be significant biomedical research problems.

Details of the biomedical project not relevant to the
technology development relationship should not be the focus of the Research
Strategy. Because this program does not provide direct support for the
collaborating biomedical investigator, the discussion in the BTRR application
should not focus on the approach or feasibility of a specific biomedical
project. It should focus on the aspects of the proposed DBPs that requires the
technology under development.

Letters
of Support: All letters of support should be included in the
most relevant component, and should not be duplicated. Letters applicable to
the entire application, such as those expressing institutional support, should
be included in the Overall component. Letters of support from investigators
specifically collaborating with Resource investigators on any TR&D, DBP, or
other projects described specifically in the application should be included in
the respective component. The purpose of letters of support is to describe the
nature of the collaborative relationship, including its scope, and any special
circumstances (e.g. materials or technology transfer, or intellectual property
agreements). Do not include letters of support from resource users whose
interactions are limited to activities described in the CE component.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Project /Performance Site Location(s)
(Community Engagement)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Community Engagement)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed
in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Community Engagement)

Budget forms appropriate for the specific component
will be included in the application package.

Note: The R&R Budget form included in many of the
component types allows for up to 100 Senior/Key Persons in section A and 100
Equipment Items in section C prior to using attachments for additional entries.
All other SF424 (R&R) instructions apply.

Support should be requested for all research, outreach,
user training, technology dissemination and project management activities
related to the CE component of the BTRR. This includes personnel and all other
materials and associated expenses. No support may be requested in the
application for CE activities conducted outside of the BTRR, such as laboratory
work undertaken by any Collaboration and Service (C&S) collaborators, or
for personnel associated with the collaborating laboratories. No funds may be
requested to support travel or accommodations for training course registrants.

PHS 398 Research Plan (Community
Engagement)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims:Describe
the aims of the Community Engagement component of the proposed center.

Research
Strategy: Describe plans for Community Engagement (CE). Plans
should focus on active engagement with the research community to provide the
broadest possible access to Resource technologies, moving those technologies
out into the community as quickly and effectively as possible. In addition to
details discussed below, the CE plan should address the following overarching
themes:

Expected
Life of the Center: Explain the anticipated arc of the technology
development program over the expected lifetime of the Resource, which should
inform plans for the progression from Resource access to widespread
dissemination of the technology. Rather than a Resource becoming essential to
the research community because of the technologies developed there, and then
maintaining that high level of technical capability in order to remain
essential, successful development and dissemination of technologies should in
most cases eventually make the Resource obsolete, generally by year 15. Present
plans consonant with this expectation. Substantial resources, with respect to
both effort and funds, should be devoted to promoting and disseminating robust
technologies and training the research community in their use.

Sustainability
Plan: Substantive plans working toward sustainable community access
to the technology should be developed, with a strong rationale for the approach
taken. It is anticipated that in most instances, technologies will be widely
disseminated beyond the Resource within, at most, five years of their
development. This will allow for multiple successive rounds of technology
development and dissemination during the life of the Resource. The optimization
of technologies to a point where dissemination is practical should be included
in the TR&D program of the Resource. A strategy for engaging the community
to promote adoption of new technologies and to achieve sustainability should be
addressed in an integrated manner in the CE component.

Unique considerations of the subject technologies and
the affected research communities may present issues for technology promotion
and adoption. Innovative plans to mitigate these obstacles should be presented.
For example, if replication of a technology outside the Resource is not
feasible, consideration should be given to how this might be overcome to make
the technology truly portable, and if not, how to ensure widespread access.

The primary purpose of this component of a BTRR is to
promote the widespread sustainable application of technologies developed by the
Resource. Historically, BTRRs have been required to include three components
that represented essential elements of the Community Engagement mission:
Collaboration and Service, Training and Dissemination. Moving forward, the
decision of which specific approaches to the community engagement process will
be employed is left to the discretion of the Resource PD/PI(s). However, all of
the elements described below must be addressed in some form, and applicants are
strongly encouraged to include specific plans for Collaboration and Service, User
Training, and Dissemination. In the absence of such plans, a specific
rationale for their absence must be provided. It is understood that some
technologies are more readily shared, replicated, or commercialized than
others, and unique constraints may dictate unique approaches. Further, BTRR
investigators are encouraged to use novel, creative approaches to engage
different segments of the biomedical research community.

At a minimum, the CE component must include detailed
plans to provide access to technologies in the Resource as they mature, and to
develop an informed, competent user base in the research community that is
prepared to adopt these technologies as they emerge from the Resource. Plans
should be presented for direct hands-on training in data acquisition and
interpretation. To the extent possible, technologies are expected to become
available outside the Resource. Plans must be presented to move technologies
out of the Resource as quickly as possible, in a manner that will promote the
broadest and most sustainable availability possible.

Each of these elements must be addressed, and should
be integrated, along with any additional elements deemed appropriate by the
applicant, to form a coherent program of Community Engagement.

Collaboration
and Service: Present plans to provide access to the advanced
technologies created in the Resource. The concentration of instrumentation,
software, methods, and expertise developed in a BTRR represents an important
resource for biomedical and clinical researchers. Explain how the BTRR will
actively engage the research community to collaborate and provide broad access
to Resource capabilities. Note that this program is not intended for support of
a Resource that is predominately focused on routine service.

Describe the overall range of C&S projects to be
supported by the Resource. Describe plans for the selection and evaluation of
C&S projects. Note that C&S projects are distinct from DBPs. These
projects may make extensive use of Resource technologies and expertise, but are
distinguished from Driving Biomedical Projects in that they do not serve as
primary drivers or as test beds for the new technologies in the early stages of
development. C&S projects generally exploit the more mature capabilities of
the Resource.

Present plans for the Resource to provide community
access to expertise in the Resource for consultation and data interpretation,
access to software and associated technical support, and access to
instrumentation for routine work by outside users. These plans may include assistance
provided to other laboratories or institutions to help them build their own
independent resources for user access. It is expected that BTRR support will be
acknowledged in papers resulting from all CE support of research, regardless of
whether BTRR staff are listed as authors. That acknowledgement should use the
NIGMS grant number. Present plans for ensuring and tracking this
acknowledgement.

The application should include a description of the
overall goals of the C&S functions of the Resource. The Resource’s approach
to, and plans for, C&S activities should be described, as well as the
manner in which service will be provided. This section should make clear the
impact of the C&S functions of the Resource on the research community,
rather than concentrating on the scientific aspects of the specific C&S
projects that are included. The BTRR should strive to conduct the majority of
its C&S projects with researchers who are outside the applicant
institution, broadening the scope of the Resource’s impact as technologies
mature.

If a charge back system that results in program
income is planned, a description of how costs are to be shared by the users
should be included. Additionally, special administrative requirements that
apply to program income must be observed. See the NIH
Grants Policy Statement Section 8.3.2.

Technology
Training for the User Community:Informing the scientific community about
the technical capabilities and accomplishments of the subject technologies
developed in a BTRR, and how these tools can be applied to their problems, is
critical. The technologies, methods, and software developed in BTRRs are
frequently sophisticated and conceptually novel. User training generally is
necessary to facilitate adoption by scientists outside the BTRR. Technology
user training for the research community should be planned and provided by the
BTRR. A BTRR must allocate sufficient resources for training both specialists
and non-specialists to make the best possible use of the new tools. The
approaches to user training do not need to be novel. The user training should
simply be well thought out, accessible, and effective. The Resource’s Training plan
should aim to build technical competence in the broader community of
researchers.

The overall goal of the user training element of BTRR
Community Engagement is expected to be twofold: to improve the general
understanding of the Resource’s technologies in the appropriate research
communities and to create a cadre of biomedical researchers from other fields
who are now trained in the use of the technology so that they can effectively
apply it in their own research.

Well-defined plans for user training should be
presented in the application. Specific methods or activities are not
prescribed. The choice of approaches should be informed by the special
constraints and opportunities presented by the circumstances of the BTRR in
question. A defining feature of BTRR user training activities is the direct
interaction between Resource personnel and the user. Note that while web-based,
self-service tutorials are highly laudable, and encouraged, this does not
represent an adequate replacement for hands-on training. Plans for tracking the
demand for and utilization of user training resources should be described.

Successful user training activities will enable
researchers to fully utilize the technologies and resources developed by the
BTRR. Examples of appropriate approaches to user training include hands-on
laboratory experience such as visits in the BTRR laboratories for researchers
from other laboratories or reciprocal visits by BTRR personnel; seminars and
lectures; short courses or symposia offered independently or in conjunction
with society meetings attended by the user community; workshops on relevant
topics that bring together researchers in multidisciplinary areas from academic
institutions, hospitals and industry for discussions on the use of the BTRRs
technology in biomedical research. Because of the increasing importance of
translational and clinical research, plans for training researchers involved in
those efforts are encouraged where appropriate.

If on-site user training and collaborative work will
be supported, describe plans to make workspace available for visiting
scientists.

Academic courses that are offered as part of the
curriculum of the Resource’s institution, and not available to those outside
the institution, should not be considered an element of the Resource’s user training
mission and should not be included in this section. Individuals benefiting from
the user training experiences may not be paid a salary in conjunction with the experience,
nor may the experience be a requirement for receipt of an academic degree.

Formal pedagogy and direct responsibility for
training of students and post-doctoral fellows are important elements of the
academic research enterprise, and it is expected that students and
post-doctoral fellows within the BTRR will play major roles in the TR&D
components of the Resource. However, those educational activities are not
considered relevant to the user training element of a BTRR, which is focused on
the external research community.

For renewal applications, a progress report on user
training activities from the previous project period should be included in this
section, including data collected as part of the aforementioned
demand/utilization tracking plans.

Technology
Dissemination:A fundamental motivation for the BTRR program is to bring
cutting-edge
technology to bear on biomedical research problems. A critical step to meeting
this objective is to share new technologies and methods as broadly as possible
in order to bring them into routine use. The DBP and CE aspects of a BTRR all
build toward this overall goal of broad dissemination.

Dissemination activities should have one objective.
Resources must promote and enable the broader use of technologies beyond the
BTRR. Informing the scientific community about the technical capabilities and
accomplishments of the subject technologies developed in a BTRR is also
critical, but it is not dissemination of the actual technology. A variety of
approaches can be proposed to meet these goals. These approaches can include,
but are not limited to: distributing and supporting software products;
transferring technologies to other laboratories directly; patenting inventions,
and licensing technologies to industry, including partnerships with small
businesses and support from the SBIR and STTR programs. Publishing articles,
books, newsletters, annual reports, or special issues of technical journals,
issuing press releases, presenting research results at meetings; conducting
workshops and conferences, and web-based training modules and tutorials are all
helpful ancillary activities that bridge training and dissemination. All BTRR
Dissemination activities must acknowledge NIGMS grant support, and cite the
NIGMS grant number.

A robust web presence is required for every BTRR.
Support from NIGMS should be acknowledged on that web site. The web site should
provide information about:

The Resource’s research focus and capabilities

A section of plain language information for the general public
about the technologies being developed and those presently available to users

Contact information

How to establish Driving Biomedical Projects or other
collaborations

How Resource collaborators and users should cite the BTRR grant

A section on current newsworthy items directed to the general
public

An image gallery that features data and results

Links to online tutorials

The availability of software, reagents, and other resources, as
applicable.

Links to other related NIH funded resources including other
BTRRs, the NIH BTRR Portal page (http://www.btrportal.org),
and the NIGMS BTRR program web page.

In addition to the BTRR web page, each Resource is
required to maintain an up-to-date presence on the Biomedical Technology
Research Resources Portal (http://www.btrportal.org/).
This site presents information on all Resources in the NIGMS and NIBIB BTRR
programs, with links to each Resource’s web page.

In Resources that are developing software, emphasis
should be placed on producing portable, well-documented, user-friendly
software, making it readily available to the user community and providing user
support. NIGMS encourages sharing of source code, consistent with the NIH
data-sharing policy. Although software is not required to be open source, if a
restrictive license will be used to distribute the software, written
justification is required in the application.

Use
of Common Data Elements in NIH-funded Research: NIH encourages the
use of the FAIR (Findable, Accessible, Interoperable and Reusable) principles
and common data elements (CDEs) in basic, clinical, and applied research,
patient registries, and other human subject research to facilitate broader and
more effective use of data and advance research across studies. CDEs are data
elements that have been identified and defined for use in multiple data sets
across different studies. Use of CDEs can facilitate data sharing and
standardization to improve data quality and enable data integration from
multiple studies and sources, including electronic health records. NIH ICs
have identified CDEs for many clinical domains (e.g., neurological disease),
types of studies (e.g. genome-wide association studies (GWAS)), types of
outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the
Global Rare Diseases Patient Registry and Data Repository). NIH has
established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in
identifying NIH-supported CDEs when developing protocols, case report forms,
and other instruments for data collection. The Portal provides guidance and
access to NIH-supported CDE initiatives and other tools and resources for the
appropriate use of CDEs and data standards in NIH-funded research.
Investigators are encouraged to consult the Portal and describe in their
applications any use they will make of NIH-supported CDEs in their projects

Plans should be described for measuring the success
of Dissemination efforts, as well as tracking the demand for and utilization of
resources provided directly by the BTRR.

A progress report of Dissemination activities from
the previous project period should be included in this section for renewal applications.

Letters
of Support: All letters of support should be included in the
most relevant component, and should not be duplicated. Letters applicable to
the entire application, such as those expressing institutional support, should
be included in the Overall component. Letters of support from investigators
specifically collaborating with Resource investigators on any TR&D, DBP, or
other projects described specifically in the application should be included in
the respective component. The purpose of letters of support is to describe the
nature of the collaborative relationship, including its scope, and any special
circumstances (e.g. materials or technology transfer, or intellectual property
agreements). Do not include letters of support from resource users whose
interactions are limited to activities described in the CE component.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Applicants should note the requirement described
above, to describe specific plans for sustainable community access to resources
developed in the BTRR.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide, with the following modifications.

The following attachments are required in the
Community Engagement component if Collaboration and Service (C&S) is
proposed as an element of Community Engagement.

Table
of Collaboration and Service Projects

Collaboration and Service projects are not required.
If present, there is no limit to the number of C&S projects that may be
proposed. If applicable, a table of all C&S projects should be provided.
For renewal applications, C&S projects from the previous funding period
should be included in the table following the listing of current and proposed
activities. Each entry in the table should include:

The collaborating investigator for the Collaboration/Service
project

The institution of the PD/PI

The title of the project

The name(s) of Resource personnel involved with the project

Start and finish dates for the project

The external funding status of the project

A brief description of the biomedical research problem that will
form the basis of the C&S project.

The rationale for and impact of the proposed BTRR effort on the
project.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Community
Engagement)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report
as described in the SF424
(R&R) Application Guide.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants administration.
NIH and Grants.gov systems check the application against many of the
application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component
Project Leads must include their eRA Commons ID in the Credential field of
the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID
in the credential field will prevent the successful submission of an electronic
application to NIH.

The applicant organization must
ensure that the DUNS number it provides on the application is the same number
used in the organization’s profile in the eRA Commons and for the System for
Award Management (SAM). Additional information may be found in the SF424
(R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application
instructions by the Center for Scientific Review, NIH. Applications that are
incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the
research community that it will serve? Is the scope of activities proposed for
the Center appropriate to meet those needs? Will successful completion of the
aims bring unique advantages or capabilities to the research community?

Will the proposed BTRR develop technical capabilities
likely to substantially enable biomedical research? Is the BTRR likely to
become an important resource for researchers?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited
to their roles in the Center? Do they have appropriate experience and training,
and have they demonstrated experience and an ongoing record of accomplishments
in managing technology development research? Do the investigators demonstrate
significant experience with coordinating collaborative basic research? If the
Center is multi-PD/PI, do the investigators have complementary and integrated
expertise and skills; are their leadership approach, governance, plans for
conflict resolution, and organizational structure appropriate for the Center?
Does the applicant have experience overseeing selection and management of
subawards, if needed?

Are the scientific and managerial credentials of the
PD/PI(s) and the credentials of other key professional and technical staff
appropriate for the needs of a BTRR? If multiple PD/PI(s) are proposed, do
they each operate in a leadership capacity regarding all components of the
BTRR?

Innovation

Does the application propose novel technologies,
including methods and instrumentation in coordinating the research projects the
Center will serve? Are the concepts, strategies, or instrumentation novel to
one type of research program or applicable in a broad sense? Is a refinement,
improvement, or new application of technologies proposed?

Approach

Are the overall strategy, operational plan, and
organizational structure well-reasoned and appropriate to accomplish the goals
of the research community the Center will serve? Will the investigators promote
strategies to ensure a robust and unbiased scientific approach across the community,
as appropriate for the work proposed? Are potential problems, alternative
strategies, and benchmarks for success presented? If the resource is in the
early stages of operation, does the proposed strategy adequately establish
feasibility and manage the risks associated with the activities of the resource?
Are an appropriate plan for work-flow and a well-established timeline
proposed? Have the investigators presented adequate plans to ensure
consideration of relevant biological variables, such as sex, for studies of
vertebrate animals or human subjects?

In Renewals, is the role of the External Advisory
Committee or in new applications plans for the committee and types of committee
members appropriate? Do the members of this committee have sufficient breadth
and ability to take an effective role in the review and guidance of the
Resource operations? In renewal applications, is there evidence that the EAC is
active? Are there plans for rotation of the members of this committee?

If other committees such as a local executive
committee are proposed, are the composition and organizational plans for these
committees adequately described? How will they benefit the Resource?

Is the research program described appropriate for the
BTRR program? Are the technology development, biomedical test-bed, and
community engagement components of the BTRR necessary and sufficient to address
the stated need? Is there synergy among all of the BTRR components?

Given the rationale motivating the overall technology
development program, is the chosen strategic direction the appropriate one to
address the defined need? Do the proposed TR&D projects constitute a
potentially effective, integrated approach to the technical goals of the
Resource? Is there synergy among the TR&D projects?

Is the organizational structure of the BTRR conducive
to its development and operation as a well-integrated multidisciplinary team? Are
the structural and procedural elements of the BTRR adequate to ensure against
fragmentation of the technology development program?

Is the sustainability plan appropriate?

Environment

Will the institutional environment in which the
Center will operate contribute to the probability of success in facilitating
the research projects it serves? Are the institutional support, equipment and
other physical resources available to the investigators adequate for the Center
proposed? Will the Center benefit from unique features of the institutional
environment, infrastructure, or personnel? Are resources available within the
scientific environment to support electronic information handling?

Are the space and resources for the BTRR, including those
for visiting scientists, appropriate and adequate? In the case of a renewal
application, is the usage of the technologies developed and supported by the
Resource appropriate and adequate? Are technologies in place and operational,
and are staff members currently on site?

Additional Review Criteria - Overall

As applicable for the resource proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections
for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.

Inclusion
of Women, Minorities, and Children

When the proposed resource involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate
Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate protection
is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

For Renewals, the committee will
consider the progress made in the last funding period.

Revisions

For Revisions, the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended for
approval by the committee, then the committee will consider whether the responses
to comments from the previous scientific review group are adequate and whether
substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the resource proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications
from Foreign Organizations

Not Applicable

Select Agent
Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.

Budget and
Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

Scored Review Criteria: Technology Research and
Development Projects, Driving Biomedical Projects, Community Engagement

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each of
the Technology Research and Development Projects, and for the Driving
Biomedical Projects and Community Engagement components.

Technology Research and Development
Projects

Is the Resource technology dynamically evolving,
state of the art, an important area for research and development in its own
right, and likely to advance the frontiers of biomedical research? Are
alternative approaches to solving technological problems presented?

Are the TR&D projects complementary and
synergistic? Does the overall TR&D program of the BTRR represent the
expression of a coherent vision?

Is there synergy between a TR&D project and the
DBP(s) in advancing the focal technology?

Is the entire arc of the technology development
process addressed in the TR&D projects? Is it clear that technology
development will be carried through to completion, including optimization for
use by non-specialists where appropriate?

What is the potential for achievement of the BTRR's
technological goals to enable biomedical research? How is this Resource unique
and useful to the community in the technological goals it is pursuing as well
as in the cluster of DBPs to which the advanced technology is being applied?

Is the Resource technology already broadly available?

Are Resource TR&D personnel suitably qualified to
lead these technically complex and specialized projects?

If Technology Development Partnerships are proposed,
are they justified? Are planned partnerships likely to result in successful
integration of partner technologies into the Resource?

In Renewal applications, is evidence provided of new
meritorious efforts and significant progress during the past grant period?

Driving Biomedical Projects

Are plans presented for the Resource staff to
continuously develop new, significant applications of the Resource technology
in the biomedical sciences through recruitment of high quality Driving
Biomedical Projects? Will the proposed DBPs serve as test beds and/or drivers
for the specific associated TR&D project(s)?

Will the DBPs advance and motivate further
technological research and development in the Resource? Is the technology
appropriate for the proposed DBPs and will it have high impact on the science
being explored in them?

Will proposed DBPs drive and/or provide test beds for
TR&D research? Are the described relationships between DBPs and TR&Ds
meaningful? In renewal applications, are DBPs making good use of the
technological advances? In renewals, is the balance right between continuing
DBPs, DBPs that have finished, and DBPs that have turned into C&S projects?
Are new DBPs in important biomedical fields being actively sought to invigorate
the Resource?

Community Engagement

Are plans for Community Engagement (CE) responsive to
community needs? Are the plans reasonable? Are the different aspects of the CE
plan integrated? Do these plans consider any unique constraints associated with
the subject technology? Are plans for technology access sustainable?

Does the CE component include detailed plans to
provide access to technologies in the Resource as they mature? If present, do
C&S projects have a national geographical distribution? For Resources that
do a substantial amount of service, are the plans for sharing costs by the
users, including fee for service systems, appropriate? Are Resource CE staff
suitably qualified? Is the BTRR technology available to outside users?

Are the CE plans likely to result in development of
an informed, competent user base in the research community? Are plans presented
for direct hands-on user training in data acquisition and interpretation? Are
the plans presented likely to result in the ability of researchers to
successfully adopt Resource technologies? Are Resource user training staff
suitably qualified? In renewal applications, have strong results accrued from
user training efforts? Are there clear metrics to assess success?

Are plans for dissemination commensurate with the
portability of the technologies? Will technologies be moved out of the Resource
quickly? Are dissemination plans likely to result in broad, sustainable
availability? Are there specific plans for technology transfer? Are plans for
tracking success of dissemination and resource demand appropriate? In renewal
applications, is there evidence of progress in dissemination of technologies?

In Resources that are developing software, is it or
will it be portable when appropriate, well documented, user-friendly, and
readily available to the user community? Have there been efforts to make both
non-expert and expert communities aware of the new technology? Is software
development pursued in a manner that will promote dissemination and widespread
adoption? Are plans likely to result in robust, stable software?

Are the plans for the web site appropriate? Do they
include the required information (the Resource’s research focus and
capabilities, technologies being developed and available, contact information,
how to collaborate, available resources)? In renewal applications, is the web
site easy to find? Does the material on the web site provide useful information
to the biomedical research community? Has there been reasonable and timely
progress in this area?

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the Center
for Scientific Review in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

Will receive a written critique.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications . Following initial peer review, recommended applications
will receive a second level of review by the National Advisory General Medical
Sciences Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

The balance and distribution of the NIGMS technology development
grant portfolio.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

A final RPPR, invention statement,
and the expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.